Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)— 510(k) K222047
Substantially EquivalentElekta Solutions AB
FDA 510(k) clearance K222047 for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant), Substantially Equivalent on 2022-10-26. Applicant: Elekta Solutions AB.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Code IWB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.